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The Effect of Ketamine on Interleukin-6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion

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ClinicalTrials.gov Identifier: NCT00978757
Recruitment Status : Completed
First Posted : September 17, 2009
Results First Posted : January 18, 2010
Last Update Posted : January 18, 2010
Sponsor:
Information provided by:
Hospital Italiano de Buenos Aires

Brief Summary:
The purpose of this study is to determine whether ketamine is effective to inhibit interleukin 6 synthesis in hepatic resections requiring temporary porto-arterial occlusion.

Condition or disease Intervention/treatment Phase
Hepatectomy Drug: Ketamine Other: Placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 4: Study of Ketamine Inhibition of Interleukin 6 in Hepatic Resections Requiring Temporary Porto-arterial Occlusion
Study Start Date : June 2001
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ketamine
Ketamine: 0.25 mg/kg, intravenously, one dose.
Drug: Ketamine
Ketamine: 0.25 mg/kg, intravenously, one dose.
Other Name: Ketamine commercially available - FADA Pharma
Placebo Comparator: Placebo
Placebo: saline solution
Other: Placebo
saline solution
Other Name: Normal saline



Primary Outcome Measures :
  1. The Effect of Ketamine on Interleukin 6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion (Pringle Maneuver) [ Time Frame: Blood samples for IL-6 levels were obtained prior to surgery, upon placement of the first intravenous ]


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 21 or older
  • Planned liver resection with Pringle maneuver lasting 30-60 minutes

Exclusion Criteria:

  • Chronic illness requiring corticosteroids
  • Cirrhosis
  • Hemodynamic instability prior to surgery
  • Diabetes
  • Sepsis
  • Surgical interventions or chemotherapy treatments within the past 30 days
  • Pregnancy
  • Illnesses that could potentially affect the hepatic circulation
  • Arterial hypertension
  • Ocular hypertension
  • Allergy to ketamine
  • Preoperative portal embolization
  • Radiofrequency ablation
  • Patients requiring emergency surgeries

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978757


Locations
Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Argentina, 1181
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
Principal Investigator: Francisco C Bonofiglio, MD PhD Hospital Italiano of Buenos Aires, Argentina

Responsible Party: Hospital Italiano of Buenos Aires, Argentina
ClinicalTrials.gov Identifier: NCT00978757     History of Changes
Other Study ID Numbers: IRB#556
First Posted: September 17, 2009    Key Record Dates
Results First Posted: January 18, 2010
Last Update Posted: January 18, 2010
Last Verified: October 2009

Keywords provided by Hospital Italiano de Buenos Aires:
hepatectomy
IL 6
organ failure
ketamine
Pringle

Additional relevant MeSH terms:
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action